Cancer Drug Developed by UAMS Professor Awarded FDA Approval

By Ben Boulden

Valchlor gel is for the topical treatment of stage 1A and 1B mycosis fungoides-type cutaneous T-cell lymphoma (CTCL), a rare form of non-Hodgkins lymphoma. Developed by Ceptaris Therapeutics, the gel is the first and only FDA-approved topical formulation of mechlorethamine, commonly known as nitrogen mustard. Patients can apply Valchlor once a day, and it dries on the skin.

Mycosis fungoides is the most common type of cutaneous T-cell lymphoma. It has no cure, and its cause is unknown. The malignant T-cells migrate to the skin, causing lesions to appear. Lesions first appear as a rash and then may grow into disfiguring tumors.

“The big problem with this skin condition is that if it is not treated, the affected T-cells can move into the lymph system,” said Crooks, who worked on the drug before joining UAMS as chair of the Department of Pharmaceutical Sciences in the College of Pharmacy. “Not only does Valchlor help treat people who have these lesions from a fungal source or ionizing radiation, with early diagnosis it can prevent CTCL.”

Crooks was a cofounder and chief scientific officer (CSO) of Yaupon Therapeutics, the company that later became Ceptaris, which is located in Malvern, Penn. He began developmental work on Valchlor in 2004. He helped solved such problems as how to chemically stabilize the drug in the topical gel formulation, and how to keep it from entering a patient’s bloodstream. He stepped down as CSO of the company in 2011 when he joined UAMS.

During his work on Valchlor, Crooks said he learned a tremendous amount about drug development, manufacturing and the FDA approval process. He is applying that knowledge to new research and new projects at UAMS, such as clinical development of new drugs for the treatment of acute myelogenous leukemia (AML), the most common form of leukemia, and for the treatment of Alzheimer’s disease.